Converted products,
such as pouches and bags, may be the last heralded of the three major
medical device packaging types, behind trays and form-fill-seal roll-stock.
But demand for them is healthy because they satisfy a variety of needs.

The Freedonia Group
Inc. (Cleveland) projects 5.7% annual growth for pouches from 1997 to
2002, reaching $336 million in the final year. Some say the market has
been even better.

That might seem
hard to believe, given that pouches and bags usually don't have the
strength of trays and aren't as efficient a packaging process as form-fill-seal.
But many companies are finding that, especially with the new materials
being used, they offer the best combination of cost and quality.

HEALTHY GROWTH
One reason for growth, says Terry Collins, product manager-converted
products at Perfecseal (Philadelphia; and Oshkosh, WI), is that "as
startup companies prevail and as their products enter the marketplace,
they can't justify going to an automated form-fill-seal process, so
they purchase premade bags and pouches."

Another growth market
is in dental devices, says David Burland, sales manager at Techlem Medical
Systems Inc. (Mississauga, ON, Canada). "They are incorporating
the use of pouches in their sterilizers, and the sharper items tend
to wind up in them as well."

Jerry Bennish, global
marketing director for Rexam Medical Packaging (Mundelein, IL), says
that the growth in the bag and pouch market mirrors that in the device
market. Growth would be even higher if some companies didn't replace
them with form-fill-seal operations, which are considered to be more
efficient for large volumes.

And another strong
area, says Phil Rosenburg, president of Technipaq Inc.(Crystal Lake,
IL), is in applications that provide a foil laminate for better barrrier
protection. "If you have a product that is sensitive to light,
oxygen, or moisture, a lot of the time the most economical choice is
a preformed pouch or bag," he says. Many of these bags and pouches
use foil as their barrier, but silicon oxide, aluminum oxidem and Aclar
are among the other options, he notes.

STRONG BUT NOT
COSTLYHeavy or sharp devices used to be the exclusive province of trays.
But now, because of material advances and industry's desire to contain
costs, bags and pouches are being considered.

While "there
is not a major tidal shift away from trays," says Carl Marotta,
president of Tolas Health Care Packaging (Feasterville, PA), "there
are tougher films available for packaging heavier devices. They often
contain nylon for puncture and abrasion resistance."

Bennish notices
the same trend. "In pouches used in hospitals, there have been
new films incorporating laminates that have a lower tendency to fracture
or tear," he says. For instance, "there have been advances
in polypropylene films that allow for extra resistance." One of
the tray's advantages over the bag or pouch is its ability to hold a
product in place. But bags and pouches are beginning to offer the same
capability."Die-cut insert cards used inside a pouch replace the
need for a tray," says Kathleen Daly Mascolo, vice president and
director of sales and marketing at Beacon Converters Inc. (Saddle Brook,
NJ). "They give the protection and organization of a tray but are
much less expensive."

These products,
Marotta says, "immobilize the part so it does not shift and push
up against the side seals. That enables people to use pouches for bigger
products." Another use along those lines, says Curt Larsen, packaging
consultant for DuPont Medical Packaging Systems (Wilmington, DE), is
to put a tray inside a pouch or header bag as a less-expensive alternative
to a heavy-gauge blister package.

Bags for custom
procedural kits are also required to be stronger as the kits get bulkier
and heavier. Collins says that, for such heavy kits, "customers
are converting to stronger films and special design features, such as
a reinforced weld seal, to prevent product push through at the header
seal."

Also a factor, says
Burland, is that "as manufacturers are consolidating purchases
and as volumes grow, products are being shipped over greater distances
and more safe-transit issues arise. The bags and pouches have to be
stronger and tougher while maintaining sterile integrity. So we see
multilayer laminates and the use of stronger substrates and heavier
gauges for more demanding applications."

DOWNGAUGINGEven though stronger, heavier materials are in demand, there remains
pressure to downgauge and provide thinner, less expensive materials
without sacrificing strength. "In the bag area, new polymers like
single-site catalysts allow for header bags with higher performance
at a lower cost," Bennish says.

The problem with
downgauging, says Larsen, is that "the purchaser or marketer who
is making this decision doesn't understand the ramifications of it and
may be circumventing the packaging engineer, if they even have one.
You can't dismiss it as 'just packaging.'" Rosenburg of Technipaq
adds that, "Even if a switch in material can give a cost savings,
there is still the reluctance to qualify new material."

DuPont's response to the lighter weight issue is Tyvek 2FS, which was
designed for form-fill seal applications but has drawn interest for
use in bags and pouches. "It is absolutely an alternative,"
Larsen says. "We don't know yet how significant a cost savings
it will be from the other forms of Tyvek, but against paper, the cost
should be a push, and you gain integrity, strength, puncture resistance,
and porosity."

Marotta agrees.
"It is possible to make some pouches with it. One limitation is
that it is a lighter weight grade than other Tyvek styles and tends
to tear or delaminate more easily. We design around it by putting coatings
on it that enable a cleaner peel."

"There have
been some good papers introduced recently with much higher surface bond
strength, which allows them to provide better fiber-free peel characteristics,"
says Eloy Cantu, global medical business development leader, Oliver
Products Co. (Grand Rapids, MI). "Still, the dominant material
in the U.S. market is Tyvek. It is the most consistent, the most puncture
resistant, and the best bacterial barrier."

Costs can be saved
another way, Bennish says. "Resin-based peel systems are replacing
more expensive coated systems. That allows you to reduce cost and improve
breathability by eliminating the coating of Tyvek."

With the increasing
use of gamma sterilization, which is suitable for film to film pouches,
there may be a rise in packages that don't use paper or Tyvek, Collins
says. If a device doesn't need a permeable material, then its manufacturer
may opt for the less expensive film-to-film option, he explains. To
prevent the product from shifting in a film-to film pouch, a heavier
material like nylon or DuPont's Surlyn might be called for, suppliers
say.

AUTOMATING FILLINGMany device makers assume that bags and pouches are not suitable
for an automated or semiautomated packaging process, so when their packaging
volume increases, they move to form-fill-seal to save labor costs.

However, About Packaging
Robotics Inc. (Boulder, CO) has developed a machine that it says offers
a way to make pouch filling more efficient. Using vacuum cups to open
the pouches, the machine fills and closes them.

"There are
three standard methods of operation," says Lynda Muhlbauer, the
firm's administrator. "The foot pedal mode allows the operator
to press a foot pedal to initiate each cycle. The timed mode cycles
the system according to a prescribed number of seconds that the operator
has input into the PLC. The automatic mode integrates the to an autofiller
by sending a signal to the filler that the pouch has been opened and
the filler should dispense product. A company can easily start with
one of the manual-fill operations and upgrade to autofill when production
or product changes warrant."

Despite the use
of a vacuum, the machine can handle porous materials like Tyvek and
paper. Since the vacuum is used only to open the bag for product insertion,
the seals are not compromised.

NICHE PRODUCTSBags and pouches have prospered because they have been able to satisfy
special niches and specific applications. For instance, "a lot
of contract packagers are using preformed pouches for small runs,"
says Douglas Marvin, accounts manager at Rollprint Packaging Products
(Addison, IL). "I have one customer who orders over 1 million pouches
a year, because there are so many different products and sizes."

"There will
always be a place in the market for a preformed pouch or bag,"
Rosenburg says. "There's not one single type of package that works
for every application."